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Hormone Sensitive Prostate CancerPhase 2NCT04182594

Cardiovascular Events in GnRH Agonist vs. Antagonist

A Phase 2 study testing Degarelix and GnRH agonist in people with Hormone Sensitive Prostate Cancer and Prostate Cancer, run by Rabin Medical Center at 1 site in Israel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to test if the use of Degarelix for 1 year associated with a lower rate of cardiovascular toxicity compared to Gonadotropin-releasing hormone (GnRH) agonists in patients with advanced prostate cancer and cardiovascular risk factors, receiving combination therapy of Androgen deprivation… Read more about this study

Who is it for?
Ages 18 to 90 years, men only
What is being tested?
Degarelix and GnRH agonist
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteIsrael
Study dates
17 Jan 2020to 17 Jan 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Locally advanced high-risk prostate cancer OR metastatic prostate cancer patients.
  • Patients are scheduled to receive a combination of either
  • primary ADT for 12 months + either chemotherapy with docetaxel OR
  • primary ADT for 12 months + second line hormonal treatment with abiraterone/ enzalutamide/ apalutamide
  • Patients with a medical history of either of the following:
  • Myocardial infarction
Show all 16Show fewer
  • Ischaemic or haemorrhagic cerebrovascular conditions
  • Arterial embolic and thrombotic events
  • Ischaemic heart disease
  • Prior coronary artery or iliofemoral artery revascularization (percutaneous or surgical procedures)
  • Peripheral vascular disease (e.g. significant stenosis (ABPI<0.9), claudication, prior vascular surgery/intervention(
  • Two out of three cardiovascular risk factors: hypertension, diabetes, current smoking.
  • Patients age 18-90 years.
  • Life expectancy of over 12 months.
  • WHO performance status of 0-2
  • Subject is able and has agreed to sign a consent form.

Who cannot join

  • Prior use of ADT in past 6 months prior to randomization. We will, however, allow prior use of anti-androgens such as Casodex, Chimax, Drogenil, and Cyprostat.
  • Known allergic reaction to Degarelix.
  • Any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule.

Trial locations and contacts

1 site in 1 country.

Yaara Ber, PhD contact

972-39376551

yaaraba1@clalit.org.il

Israel1 site

  • Rabin Medical Center - Beilinson Hospital

    Petah Tikva, 4941492

    Yaara Ber, PhD, 972-3-9376553, yaaraba1@clalit.org.il

    David Margel, MD, PhD, 972-3-9376553, sdmargel@gmail.com

Other trials in Israel

About this study

Official title: A Phase-II, Randomized, Assessor-Blind, Controlled Trial Comparing the Occurrence of Cardiovascular Events in Patients With Prostate Cancer and Cardiovascular Risk Factors Receiving Degarelix or GnRH Agonist

The purpose of this study is to test if the use of Degarelix for 1 year associated with a lower rate of cardiovascular toxicity compared to Gonadotropin-releasing hormone (GnRH) agonists in patients with advanced prostate cancer and cardiovascular risk factors, receiving combination therapy of Androgen deprivation therapy (ADT) and second line hormonal or chemotherapy?

Read the detailed description

Study design: Randomized phase-2, open label superiority study of the use of ADT combined with second line hormonal or chemotherapy in men with advanced prostate cancer and pre-existing cardiovascular risks.

Study population: Subjects with pre-existing cardiovascular risk with locally advanced or metastatic prostate cancer and scheduled to start ADT in combination with either second line hormonal or chemotherapy. We will exclude patients with use of ADT 6 months prior to randomization.

Intervention- Two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months.

Control- GnRH agonist at the discretion of the treating Urologist/Oncologist for 1 year.

Study Time line- The intervention phase will be for one year. During this year, follow-up visits will occur every 3 months. At each visit, we will assess the occurrence of cardiac-related events. In addition, Protein-specific Antigen (PSA) test will be performed each visit. At baseline, 3, 6 and 12 months cardiac biomarkers and lab measurements will be taken. Echocardiogram will be performed at baseline, 6, 9 and 12 months. In addition, cardio-vascular related events and hospitalizations will be monitored for additional 5 years.

Primary endpoint: To compare time to first cardiovascular event of patients with advanced prostate cancer treated for one year with Degarelix vs. GnRH agonist. This will be a composite outcome composed of: Death, Cerebrovascular accident (CVA), Myocardial infarction (MI), Transient ischemic attack (TIA), cardiac emergency room visits, heart catheterization.

Secondary endpoints: To compare time to first major adverse cardiovascular and cerebrovascular event (MACCE)- (Death, CVA, MI, heart catheterization with stent) as estimated by the cumulated probability at the 1-year timepoint of patients with advanced prostate cancer treated for one year with Degarelix vs. LHRH agonist. To compare cardiovascular biomarker levels of patients with advanced prostate cancer treated with Degarelix vs. GnRH agonist. To compare change in cardiac function as measured by Echocardiography in 6,9 and 12 months.

Study impact- This study has the potential to cause a paradigm shift. If we indeed demonstrate that Degarelix is associated with less cardiovascular toxicity with clinical significance, we expect that most urologist, as well as patients, will prefer Degarelix over all other ADT.

Being tested
Degarelix, GnRH agonist
Medical subject headings
Prostatic Neoplasms, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DegarelixDrug

    Also called Firmagon

    Treatment will start with two injections of 120 mg each followed by maintenance of a single injection of 80 mg administered every 28 days

  • GnRH agonistDrug

    GnRH agonist at the discretion of the treating Urologist/Oncologist for 1 year

Study groups in NCT04182594
Study groupRoleWhat they receive
DegarelixExperimentalGnRH Antagonist
Receives: Drug: Degarelix
GnRH-agonistActive comparatorGnRH Agonist
Receives: Drug: GnRH agonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. time to first cardiovascular event

    To compare time to first cardiovascular event as estimated by the cumulated probability at the 1-year time-point of patients with advanced prostate cancer treated for one year with Degarelix vs. GnRH agonist. This will be a composite outcome composed of: Death, CVA, MI, TIA, cardiac emergency room visits, heart catheterization.

    Measured: 1 year

Secondary outcomes (10)

  1. time to first MACCE event

    To compare time to first MACCE event as estimated by the cumulated probability at the 1-year timepoint of patients with advanced prostate cancer treated with Degarelix vs. GnRH agonist and combination therapy.

    MACCE will be defined as:

    1. Death of any cause
    2. MI
    3. CVA
    4. Percutaneous coronary intervention, (PCI) with stent insertion

    Measured: 1 year

  2. cardiac echocardiography

    To compare change in ejection fraction (EF) as measured by cardiac echocardiography of patients with advanced prostate cancer treated with Degarelix vs. GnRH agonist, at baseline, six-, nine- and twelve-months of combination treatment.

    Measured: 1 year

  3. Hormonal Profile

    To compare testosterone serum levels (ng/dL) of patients with advanced prostate cancer treated with Degarelix vs. GnRH agonist, at baseline, three-, six- and twelve-months of combination treatment.

    Measured: 1 year

  4. NTproBNP levels

    To compare levels of NTproBNP (pg/mL) in patients with advanced prostate cancer treated with Degarelix vs. GnRH agonist, at baseline, three-, six-, nine- and twelve-months of combination treatment.

    Measured: 1 year

  5. Adverse events

    To compare rate of other adverse events in patients with advanced prostate cancer treated with Degarelix vs GnRH agonist and combination therapy.

    Measured: 1 year

  6. PSA levles

    To compare PSA serum levels (ng/mL) of patients with advanced prostate cancer treated with Degarelix vs. GnRH agonist, at baseline, three-, six- nine- and twelve-months of combination treatment.

    Measured: 1 year

  7. BMI

    To compare changes in body mass index (BMI) in patients with advanced prostate cancer treated with Degarelix vs. GnRH agonist, at baseline, three-, six- and twelve-months of combination treatment.

    Measured: 1 year

  8. Quality of life: FACT-P questionnaire

    To compare the quality of life by self-reported FACT-P questionnaire, by patients with advanced prostate cancer treated with Degarelix vs. GnRH agonist, at baseline, three-, six- and twelve-months of combination treatment

    Measured: 1 year

  9. Glucose profile

    To compare glucose levels (mg/dL) in patients with advanced prostate cancer treated with Degarelix vs GnRH agonist, at baseline, three-, six- and twelve-months of combination treatment.

    Measured: 1 year

  10. Cholesterol levles

    To compare Cholesterol serum levels (mg/dL) of patients with advanced prostate cancer treated with Degarelix vs. GnRH agonist, at baseline, three-, six- nine- and twelve-months of combination treatment.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2019
  2. Study start17 Jan 2020 (estimated)
  3. Primary completion17 Jan 2023 (estimated)
  4. Study completion17 Jan 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04182594
Sponsor's protocol ID
0670-19-RMC
Status last verified
Oct 2019
First submitted
24 Oct 2019
Last updated
2 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zengerling F, Jakob JJ, Schmidt S, Meerpohl JJ, Blumle A, Schmucker C, Mayer B, Kunath F. Degarelix for treating advanced hormone-sensitive prostate cancer. Cochrane Database Syst Rev. 2021 Aug 5;8(8):CD012548. doi: 10.1002/14651858.CD012548.pub2.

    PubMed 34350976

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Degarelix and GnRH agonist in people with Hormone Sensitive Prostate Cancer and Prostate Cancer, run by Rabin Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yaara Ber, PhD (972-39376551, yaaraba1@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

time to first cardiovascular event (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04182594, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2019.

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